Cleared Traditional

K964079 - SPEEDBAND MULTIPLE BAND LIGATOR

K964079 is an FDA 510(k) clearance for SPEEDBAND MULTIPLE BAND LIGATOR, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K964079 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
125d
Days
Class 2
Risk

K964079 is an FDA 510(k) clearance for the SPEEDBAND MULTIPLE BAND LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on February 13, 1997 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K964079

510(k) Number K964079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date February 13, 1997
Days to Decision 125 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 131d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FHN Device Classification - Class 2, Special Controls

Product Code FHN Ligator, Hemorrhoidal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FHN Ligator, Hemorrhoidal

All 13
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K964079.
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
K981669 · Boston Scientific Corp · Jun 1998
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · Wilson-Cook Medical, Inc. · Jan 1998
O'REGAN LIGATOR
K963166 · Patrick J. O'Regan · May 1997
SOLO BAND LIGATOR
K960020 · Surcraft, LLC · Apr 1996
SPEEDBAND
K952262 · Boston Scientific Corp · Feb 1996
1/2 CM REAR TIP EXTENDER (RTE)
K882297 · American Medical Systems, Inc. · Jun 1988